Linagliptin EG

Package leaflet: Information for the patient

LINAGLIPTIN EG 5 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, because it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet

1. What Linagliptin EG is and what it is used for
2. What you need to know before taking Linagliptin EG
3. How to take Linagliptin EG
4. Possible side effects
5. How to store Linagliptin EG
6. Contents of the pack and other information

1. What Linagliptin EG is and what it is used for

Linagliptin EG contains the active substance linagliptin, which belongs to a class of medicines called
"oral antidiabetics". Oral antidiabetics are used to treat high blood sugar levels. These medicines work by helping the body to reduce blood sugar levels.
Linagliptin EG is used in "type 2 diabetes" in adults when the condition cannot be adequately controlled with a single oral antidiabetic medicine (metformin or sulphonylureas) or with diet and exercise alone. Linagliptin EG may be used together with other antidiabetic medicines, such as
metformin, sulphonylureas (e.g. glimepiride, glipizide), empagliflozin or insulin.
It is important that you continue to follow your doctor’s or nurse’s advice regarding diet and
physical exercise.

2. What you need to know before taking Linagliptin EG

Do not take Linagliptin EG

• if you are allergic to linagliptin or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor, pharmacist or nurse before taking Linagliptin EG if:

• you have type 1 diabetes (your body does not produce insulin) or diabetic ketoacidosis (a diabetes complication with high blood sugar levels, rapid weight loss, nausea or vomiting). Linagliptin EG must not be used to treat these conditions;
• you are taking a diabetes medicine known as a 'sulfonylurea' (e.g. glimepiride, glipizide); your doctor may decide to reduce your sulfonylurea dose when taken together with Linagliptin EG to prevent your blood sugar from becoming too low;
• you have had allergic reactions to any other medicine you take to control your blood sugar levels;
• you have or have had a disease of the pancreas.

If you experience symptoms of acute pancreatitis, such as persistent and severe stomach pain (abdominal pain), you must consult your doctor.
The appearance of blisters on the skin could be a sign of a condition called bullous pemphigoid. Your doctor may ask you to stop treatment with Linagliptin EG.
Skin lesions are a common complication of diabetes. It is advisable to follow the skin and foot care recommendations provided by your doctor or nurse.

Children and adolescents
Linagliptin EG is not recommended for use in children and adolescents under 18 years of age.

Other medicines and Linagliptin EG
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
In particular, tell your doctor if you are taking medicines containing any of the following active substances:

• carbamazepine, phenobarbital or phenytoin. These may be used to control epileptic seizures or chronic pain;
• rifampicin. This is an antibiotic used to treat infections such as tuberculosis.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
It is not known whether linagliptin is harmful to the unborn baby. Therefore, it is preferable to avoid taking Linagliptin EG during pregnancy.
It is not known whether linagliptin is excreted in breast milk. Your doctor will decide whether to discontinue breastfeeding or to discontinue/abstain from treatment with Linagliptin EG.

Driving and using machines
Linagliptin EG has no or negligible effects on the ability to drive and use machines.
However, taking Linagliptin EG together with medicines called sulfonylureas and/or insulin may cause blood sugar levels to become too low (hypoglycaemia), which may affect your ability to drive and use machines or work without protective barriers. Nevertheless, you may be advised to monitor your blood glucose more frequently to minimize the risk of hypoglycaemia, especially when Linagliptin EG is used in combination with sulfonylureas and/or insulin.

3. How to take Linagliptin EG

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dosage
The recommended dose of Linagliptin EG is one 5 mg tablet once daily.
Method of administration
Oral administration. Linagliptin EG may be taken with or without food.
Your doctor may prescribe Linagliptin EG in combination with another oral antidiabetic medicine. Remember to take all your medicines as prescribed by your doctor to achieve the best possible health outcomes.
If you take more Linagliptin EG than you should
If you take more Linagliptin EG than prescribed, contact your doctor immediately.
If you forget to take Linagliptin EG

• if you forget to take a dose of Linagliptin EG, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose.
• Do not take a double dose to make up for the missed dose. Never take two doses on the same day.

If you stop taking Linagliptin EG
Do not stop treatment with Linagliptin EG without first consulting your doctor. Blood sugar levels may rise when you discontinue treatment with Linagliptin EG.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Some symptoms require immediate medical attention:
YOU MUST STOP taking Linagliptin EG and contact your doctor immediately if you notice
the onset of any of the following serious side effects:
Very common (may affect more than 1 in 10 people)

• symptoms of low blood sugar levels: trembling, sweating, anxiety, blurred vision, tingling of the lips, paleness, mood changes or confusion (hypoglycaemia). Hypoglycaemia is an adverse effect observed when linagliptin is taken together with metformin and a sulfonylurea.

Rare (may affect up to 1 in 1,000 people)

• severe and persistent pain in the abdomen (stomach area), which may extend to the back, as well as nausea and vomiting. These may be signs of inflammation of the pancreas (pancreatitis).

STOP taking Linagliptin EG and contact a doctor immediately if you notice
any of the following signs or symptoms of an allergic reaction:
Uncommon (may affect up to 1 in 100 people)

• allergic reactions (hypersensitivity), including wheezing and shortness of breath (bronchial hyperreactivity);
• skin rash.

Rare (may affect up to 1 in 1,000 people)

• hives;
• swelling of the face, lips, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema).  Your doctor may prescribe a medicine to treat the allergic reaction and a different medicine for diabetes.

Other side effects
Common (may affect up to 1 in 10 people)

• increased levels of the enzyme lipase in the blood.

Uncommon (may affect up to 1 in 100 people)

• inflammation of the nose or throat (rhinopharyngitis);
• cough;
• constipation (in combination with insulin);
• increased levels of amylase in the blood.

Rare (may affect up to 1 in 1,000 people)

• blisters on the skin (bullous pemphigoid).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Linagliptin EG

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after the wording
“EXP.” The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Linagliptin EG contains
The active substance is linagliptin. Each film-coated tablet contains 5 mg of linagliptin.
The other components are:

• Tablet core: microcrystalline cellulose, hypromellose 2208, crospovidone type A, anhydrous colloidal silica, magnesium stearate.
• Tablet coating: hypromellose 2910, talc, titanium dioxide (E171), macrogol (3350), iron oxide red (E172).

Description of the appearance of Linagliptin EG and package contents
Linagliptin EG 5 mg tablets are available as film-coated, round, biconvex, reddish-grey tablets.
The tablets (measuring 8 mm x 5 mm) are supplied in blisters made of a combined Opa-Al-PVC sheet sealed with an aluminium foil.
Pack sizes:
Blisters: 10, 28, 30, 56, 90, 100 tablets.
Unit-dose divisible blisters: 10x1, 28x1, 30x1, 56x1, 90x1, 100x1 tablets.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EG S.p.A., Via Pavia 6, 20136 Milano, Italy

Manufacturers
Stada Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel – Germany
Stada Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna – Austria
Clonmel Healthcare Limited
3 Waterford Road
E91 D768 Co. Tipperary – Ireland

This medicinal product is authorised in the European Economic Area countries under the following names:
AT Linagliptin STADA 5 mg Filmtabletten
BE Linagliptin EG 5mg filmomhulde tabletten
CZ Linagliptin STADA
DK Linagliptin STADA
ES Linagliptina STADA 5mg comprimidos recubiertos con película EFG
FI Linagliptin STADA 5 mg kalvopäällysteiset tabletit
HU Linagliptin Stada 5 mg filmtabletta
IE Linagliptin Clonmel 5 mg film-coated tablets
IS Linagliptin STADA filmuhúðaðar töflur
IT Linagliptin EG
LU Linagliptin EG 5mg comprimés pelliculés
PT Linagliptina Ciclum
SE Linagliptin STADA 5 mg filmdragerade tabletter
SI Linagliptin STADA 5 mg filmsko obložene tablete
SK Linagliptin STADA 5mg filmom obalené tablety